BIOVIE INC.
BIVI evidence brief
What we can confirm
- BioSniper Score:
- 6.9 / 10
- Market Cap:
- $16.3M
- Lead Asset:
- bezisterim (NE3107) (Phase 3)
What it means
What to watch
Prepared research question
What matters most for BIVI—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · BIVI
BioVie Inc. is a clinical-stage biopharmaceutical company developing bezisterim, an oral small-molecule drug candidate for neurodegenerative diseases and advanced liver disease, with ongoing Phase 2 and Phase 3 trials.
Key risk: No product revenue
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Market Cap
$16.3M
Cash Runway
—
Lead Asset
bezisterim (NE3107) (Phase 3)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate for BIOVIE INC..
Similar companies
BioVie Inc. is a clinical-stage biopharmaceutical company developing bezisterim, an oral small-molecule drug candidate for neurodegenerative diseases and advanced liver disease, with ongoing Phase 2 and Phase 3 trials.
- BioVie is a clinical-stage company developing drug therapies for neurological, neurodegenerative, and advanced liver disease [sec · filed 2026-08-14].
- Its lead candidate, bezisterim (NE3107), is an orally bioavailable, BBB-permeable insulin-sensitizer and anti-inflammatory agent [sec · filed 2026-07-17].
- The company reported cash & equivalents of $9.0M and shareholders' equity of $10.3M as of 2026-06-30 [latest reported financials].
- BioVie has not generated any product revenues and expects none until regulatory approval is obtained [sec · filed 2026-07-17].
- The ADDRESS-LC Phase 2 trial for Long COVID completed the treatment phase in August 2026, with topline data expected in September 2026 [news · published 2026-08-31].
What works
- Bezisterim is an orally bioavailable, BBB-permeable small molecule with a mechanism that inhibits ERK and NFκB pathways, potentially offering a differentiated approach to neuroinflammation and insulin resistance [sec · filed 2026-07-17].
- The company has advanced bezisterim into Phase 3 for Parkinson's disease after FDA alignment on trial design [news · published 2026-09-08].
- The ADDRESS-LC Phase 2 trial for Long COVID is fully funded by a U.S. grant and has completed the treatment phase, with topline data imminent [news · published 2026-05-26] [news · published 2026-08-31].
What to weigh
- BioVie has no product revenues and does not expect any until regulatory approval, creating a high dependency on external financing [sec · filed 2026-07-17].
- The company's cash position of $9.0M as of 2026-06-30 is limited relative to the costs of late-stage clinical development and potential commercialization [latest reported financials].
- Additional financing will be required to fund R&D, and failure to obtain it could materially harm the business [sec · filed 2026-07-17].
- The company's pipeline is heavily reliant on a single drug candidate, bezisterim, which concentrates risk [pipeline].
From the filings
Quoted directly from source documents.
BioVie is a clinical-stage company developing drug therapies for neurological, neurodegenerative, and advanced liver disease.
“We are a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease.”
SEC filings · August 14, 2026
Bezisterim is an orally bioavailable, BBB-permeable insulin-sensitizer that is also anti-inflammatory.
“the Company's drug candidate bezisterim is an orally bioavailable, Blood Brain Barrier ("BBB")-permeable, insulin-sensitizer that is also anti-inflammatory.”
SEC filings · July 17, 2026
BioVie has not generated any product revenues and does not expect to until regulatory approval.
“We have not generated any product revenues, and do not expect to generate any revenues until, and only if, we develop, and receive approval to sell our product candidates from the FDA and other regulatory authorities for our product candidates.”
SEC filings · July 17, 2026
Risks & what to watch (4)›
Key risks
- No product revenue — BioVie has no product revenues and expects none until regulatory approval, creating financial strain [sec · filed 2026-07-17].
- Limited cash runway — Cash & equivalents of $9.0M as of 2026-06-30 may be insufficient to complete late-stage trials without additional financing [latest reported financials].
- Single-drug dependency — The pipeline is heavily concentrated on bezisterim, increasing risk if clinical or regulatory setbacks occur [pipeline].
- Financing requirement — Additional financing is required for R&D; failure to obtain it could materially harm the business [sec · filed 2026-07-17].
What to watch
- Topline data from the ADDRESS-LC Phase 2 trial for Long COVID, expected in September 2026 [news · published 2026-08-31].
- Initiation and progress of the Phase 3 Parkinson's disease trial following FDA alignment [news · published 2026-09-08].
- Any new financing or partnership announcements given the company's cash position and need for additional funding [sec · filed 2026-07-17].
Sources: News · Pipeline · SEC filings · SEC MD&A · Generated October 4, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.39
Lead: Phase 3
1 candidate
No upcoming catalysts tracked
No insider transactions in the last 180 days
Pipeline
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
33
Total value held
$1.3M
| Holder | Shares | Value |
|---|---|---|
| diametric capital, lp | 370,000 | $518K |
| prelude capital management, llc | 92,063 | $129K |
| geode capital management, llc | 84,203 | $118K |
| vanguard capital management llc | 84,067 | $118K |
| morgan stanley | 75,221 | $105K |
| renaissance technologies llc | 67,918 | $95K |
| citadel advisors llc | 45,292 | $63K |
| vanguard fiduciary trust co | 37,557 | $53K |
| jane street group, llc | 22,791 | $32K |
| xtx topco ltd | 21,226 | $30K |
Showing top 10 of 33 institutional holders of BIOVIE INC.. Open the full 13F history after sign-in.
Short Interest
as of May 20, 2026- % of float
- 2.4%
- Days to cover
- 2.5
- Shares short
- 177,085
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
BIVI short interestGovernance
Frequently asked questions
What is the AI investment thesis for BIOVIE INC.?
BioVie Inc. is a clinical-stage biopharmaceutical company developing bezisterim, an oral small-molecule drug candidate for neurodegenerative diseases and advanced liver disease, with ongoing Phase 2 and Phase 3 trials.
What is BIOVIE INC.'s lead drug candidate?
BIOVIE INC.'s most advanced tracked candidate is bezisterim (NE3107) (Phase 3) for Parkinsons Disease (PD); Long COVID.
Who is the CEO of BIOVIE INC.?
Mr. Cuong Viet Do M.B.A. is the chief executive officer of BIOVIE INC. (BIVI).
Where is BIOVIE INC. headquartered?
BIOVIE INC. (BIVI) is headquartered in Carson City, NV, United States.
What therapeutic areas does BIOVIE INC. focus on?
BIOVIE INC. develops therapies across Neurology, Infectious Disease.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.